AcuMatch

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: AcuMatch FDA UDI
Generic Name: Osteotomy guide, reusable FDA UDI
Device Name: OSTEOTOMY GUIDE, M-SERIES FDA UDI
Model / Reference: 151-00-00 FDA UDI
Description: OSTEOTOMY GUIDE, M-SERIES FDA UDI

Identifiers

Catalog Number: 151-00-00 FDA UDI
Primary DI / UDI-DI: 10885862028808 FDA UDI
510(k) Number: K010120 FDA UDI
K011081 FDA UDI
K032964 FDA UDI
K051858 FDA UDI
K993736 FDA UDI
FDA Product Code: LZO FDA UDI
LPH FDA UDI
JDI FDA UDI
LWJ FDA UDI
GMDN Term: Osteotomy guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 FDA UDI
888.3350 FDA UDI
888.3360 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

AcuMatch by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K010120 also covers:

AcuMatch — Exactech, Inc.

K011081 also covers:

AcuMatch — Exactech, Inc.

K032964 also covers:

AcuMatch — Exactech, Inc.

K051858 also covers:

AcuMatch — Exactech, Inc.

K993736 also covers:

AcuMatch — Exactech, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Exactech, Inc.

Sources (1)

FDA UDI 6471ab51-be0b-423d-a9e1-b6e3d3c0ed8b 36 fields · synced Jun 1, 2026